Corrective Actions – Current expectation of ISO 13485 and FDA auditors
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Instructor Profile:
Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well quality system requirements for other area such as Europe and Canada.
Her background in digital systems engineering enables her to facilitate design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description: Earlier, ISO auditors have trained companies on the difference between Corrections (fixing the problem) and Corrective Actions, fixing the root cause of the problem. However, now, although corrections are usually being done, they are done under other portions of ISO 13485, such as control of nonconforming product and customer feedback/ complaints.
Even though ISO 13485 requirements for Corrective Actions stress finding and correcting the root cause of a non-conformity, which is the essence of Corrective Action, that is not enough. Containment and Correction must now be an integral part of your system. With FDA's increasing emphasis on enforcement, doing robust corrections and corrective actions is a must.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Why Should you Attend: This presentation will benefit all those involved with internal or supplier corrective actions. If you issue corrective actions, you need to know what to expect of those assigned corrective actions, and often help the assignee understand the expectations. If you are assigned to complete a corrective action, you need to know what is to be expected of you in terms of investigation, analysis, and both correction and corrective actions.
If you manage the corrective action system or those doing corrective actions, it is also important that you understand what you outside auditors expect of a strong CAPA system. So that means almost anyone working within a medical device quality system could benefit from understanding the CAPA system.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit: This webinar will provide valuable assistance to all professionals in:
Quality Management CAPA coordinators Quality Engineers Engineers doing Corrective Actions Operations managers Manufacturing Engineers Quality auditors Medical device Consultants
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Live Session - How it works Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf formate will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve Get certification of attendance.
Recorded Session - How it works A link will be provided to you upon purchase of the recorded session Please click on the link to access the session Presentation handouts in pdf formate will be mailed to you Get certification of attendance. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Get Connected With Us: www.onlinecompliancepanel.com
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com